Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence, Predictors and Prognostic Significance in a Tertiary Care Centre

October 20, 2016 updated by: DR GANESH ADAIKKALAVAN M, Postgraduate Institute of Medical Education and Research

Sodium Imbalance in Traumatic Brain Injury Patients: Prevalence,Predictors and Prognostic Significance in a Tertiary Care Centre

Observational study about prevalence, predictors of sodium imbalance and prognostic significance.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Recruiting
        • Post Graduate Institute of Medical Education and Research
        • Contact:
          • DR NIDHI PANDA, MD ANAESTHESIA
          • Phone Number: +91 7087009525
          • Email: nidhibp@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult and paediatric patients with isolated traumatic brain injury admitted in ICU in PGIMER

Description

Inclusion Criteria:

  • adult and paediatric patients with isolated head injury

Exclusion Criteria:

  • age more than 80 years, patient admitted after 24 hours of trauma, chronic kidney disease, chronic liver disease, associated chest trauma, abdominal trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with sodium imbalance
patients without sodium imbalance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlate prevalence of sodium imbalance with severity of traumatic brain injury by biochemistry lab reports
Time Frame: first 10 days after admission in icu or discharge whichever is earlier
first 10 days after admission in icu or discharge whichever is earlier

Secondary Outcome Measures

Outcome Measure
Time Frame
predisposing factors for development of sodium imbalance in traumatic brain injury patients by logistic regression analysis of data
Time Frame: first 10 days after admission in icu or discharge whichever is earlier
first 10 days after admission in icu or discharge whichever is earlier
relationship between sodium imbalance and outcome in traumatic brain injury patients by assessing Glasgow outcome score telephonically
Time Frame: 1st and 3rd month after discharge
1st and 3rd month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

October 20, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Na TBI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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